Isokinetic Performance and Function After Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

Isokinetic Performance and Function Are Similar 12 Months After Total Hip Arthroplasty Applied With a Posterior or Anterolateral Approach: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640740
• Other study ID #: E-17-1415
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2020
• Source: Gulhane Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are ongoing debates on the effects of the surgical approach on outcome after total hip arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the abductor arm can be occured and related detrimental effects can diminish the post-operative outcomes. In this first randomized controlled trial in the literature on this subject, isokinetic performance and patient-reported functional outcomes were evaluated in patients undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral approach (ALA), at 6 and 12 months postoperatively.

Description:

Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and 12 months postoperatively, with flexion, extension and abduction strength measurements and the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are blinded to the study groups.All data are calculated as mean and standard deviation values. The Student's t-test is used for statistical analysis of the patient data. Statistical calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients aged 55 to 80 years unilateral primary hip osteoarthritis -

Exclusion Criteria:

bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous hip surgery neuromuscular diseases

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• hip arthroplasty
two different approaches of total hip arthroplasty

Locations

Country	Name	City	State
Turkey	Gulhane Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	isokinetic test	isokinetic test during flexion, extension and abduction of the hip	Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results
Secondary	Harris Hip Score	Functional score of the hip. Harris Hip Score: 100-90: Excellent 89-80:Good 79-70:Fair below 70:Poor	Change from preoperativeHarris Hip Score results at 6th months and 12th months iHarris Hip Score results